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临床试验/CTRI/2024/06/069546
CTRI/2024/06/069546尚未招募不适用

Fortification of Breast Milk With Preterm Formula Powder vs Human Milk Fortifier in Preterm VLBW Neonates :A Randomized clinical Trial

Dr Geeta Gathwala1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年7月16日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
1.Rate of in hospital weight gain in g/kg/d from the day of randomisation to the day of discharge.

研究概览

简要总结

Human milk though an established feeding option is not sufficient to achieve the intrauterine growth rates in preterm neonates. Studies have shown fortification of  breast milk with HMF results in net nutrient retention comparable to expected intrauterine rate of accretion in preterms .In this study we planned to compare effficacy of fortification of breast milk with LACTODEX LBW formula and LACTODEX HMF in terms of weight gain in preterm VLBW neonates. Neonates less than or equal to 32 weeks of gestation and appropriate for gestational age with birth weight less than 1500 grams were included and randomised . Expressed breast milk was fortified with LACTODEX LBW formula and LACTODEX HMF. Enrolled neonates will be followed up with weekly anthropometric audits (weight ,length, head circumference). in case of lack of adequate weight gain i.e less than less than 15g/kg/d during the weekly audit , neonates will be assessed for systemic causes , if no systemic were identified feed will be increased to 200mg/kg/d.  

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
1.00 Day(s) 至 2.00 Month(s)(—)
性别
All

入选标准

  • 1.Preterm neonates born at ≤32 weeks of gestation and appropriate for gestational age (AGA).
  • Birth weight less than 1500 g
  • Accepting oral feeds of at least 100ml/kg/day
  • Consuming 75% of milk or more as EBM at enrolment.

排除标准

  • 1.Neonates with major congenital anomalies 2.Neonates with severe birth asphyxia.

结局指标

主要结局

1.Rate of in hospital weight gain in g/kg/d from the day of randomisation to the day of discharge.

时间窗: Initially at the time of admission and then daily till discharge

次要结局

  • 1.Weekly length gain & weekly head circumference gain(2. Feed intolerance)

研究者

发起方
Dr Geeta Gathwala
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Geeta Gathwala

Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences(PGIMS) Rohtak HARYANA

研究点 (1)

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